Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds

Diabetic Foot Ulcer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01493895
• Other study ID #: becure-CTIL-HMO
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: December 15, 2011
• Last updated: March 21, 2013

Study information

• Verified date: March 2013
• Source: Hadassah Medical Organization
• Contact: Meir Liebergall, Prof.
• Phone: 972-2-6776342
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

For centuries, light has been a well-known and effective healing method. In the beginning of the 20th century there was a first attempt to condense light energy and distribute it in higher levels, a use that was successfully applied on many soldiers wounded in the Second World War. The laser, which is based on the quantum phenomenon of stimulated emission, was first demonstrated in the beginning of the 1960s and immediately received many applications in all areas of medicine.Many different studies were carried out in the past decade trying to assess the effect of laser therapy on properties of healing wounds. This study aim to assess the efficacy and safety of Low-Level Laser Therapy (LLLT) in the treatment of non-healing diabetic foot ulcers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Known Diabetes mellitus

2. With an active chronic wound in the foot, that has been treated conventionally for over 3 months.

3. No known osteomyelitis.

4. Size of wound: 1-8 cm2.

5. Ages: 21 - 75

6. Gender: male and female

Exclusion Criteria:

1. Signs of osteomyelitis.

2. The ability to probe to bone with the presence of local or systemic infection and suggestive radiological features provided a clinical diagnosis of osteomyelitis.

3. There is active osteomyelitis in the bone underlying the ulcer.

4. Pregnant women.

5. Children under 21.

6. Presence of or known cancerous comorbidity.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer

Intervention

Device:
• standard hoem treatment
All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care. Every treatment will consist of the following steps: A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water. Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method.
• LLLT-808 B-cure laser machine
From the day of entering the study, ulcers will be treated twice daily regardless of the treatment that was used until then. All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care. Every treatment will consist of the following steps: A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water. Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method. The part of the laser machine from which the laser beam is radiating - the beam guard, will be cleaned with a disposable swab of 70% alcohol. The cleaning will be performed while the machine is pointing downwards.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of b-cure laser in patients with diabetes mellitus induced lower leg skin ulcers	the efficacy will be assesed using measurement of wound depth.		No
Secondary	safety	safety will be evaluated by counting advese events in each group.		Yes